CHICLIDA 25 mg LOZENGES

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Chiclida 25 mg lozenges

Meclozine hydrochloride

Contents of the package leaflet:

1. What is Chiclida and what is it used for
2. What you need to know before taking Chiclida
3. How to take Chiclida
4. Possible side effects
5. Storage of Chiclida
6. Contents of the pack and further information

1. What is Chiclida and what is it used for

Meclozine hydrochloride, the active substance of Chiclida, belongs to the group of medicines called antihistamines, used against motion sickness.

Chiclida is indicated for the prevention and treatment of symptoms of motion sickness caused by land, sea, or air travel, such as nausea, vomiting, and/or vertigo in adults and adolescents over 12 years of age.

You should consult a doctor if it worsens or does not improve after 7 days.

2. What you need to know before taking Chiclida

Do not take Chiclida

• If you are allergic to Meclozine hydrochloride or to any of the other components of this medicine (listed in section 6).
• If you have increased intraocular pressure (glaucoma).
• If you have prostate enlargement (prostatic hypertrophy).
• If you have a disease that causes obstruction of the gastrointestinal or urinary tract.
• If you have asthma.
• If you have diabetes.
• Children under 6 years of age.

Warnings and precautions

Consult your doctor or pharmacist before taking Chiclida:

• If you have seizures with convulsive movements, with or without loss of consciousness (epilepsy).
• If you are over 65 years old, dry mouth, urinary retention, glaucoma, nausea, dizziness, sedation, confusion, low blood pressure (hypotension), or hyperexcitability may occur.
• If you are taking any medication that causes ear toxicity, as symptoms of these toxic effects, such as ringing in the ears, dizziness, or vertigo, may be masked.
• If you have any liver or kidney disease or disorder, as the concentration of the active substance may increase.
• If you have any heart disease or disorder, such as cardiac arrhythmia, hypertension, severe muscle weakness (myasthenia gravis), stomach or intestinal ulcers.
• If you suspect you have symptoms of appendicitis, such as nausea, vomiting, or abdominal cramps. It is recommended to consult a doctor to rule out the presence or absence of appendicitis.

Avoid exposure to the sun while taking this medicine.

If you are allergic to any other antihistamine, it is not recommended to take this medicine.

Interference with laboratory tests

If you are going to have a skin test that uses allergens, inform your doctor that you are taking this medicine, as it may alter the results.

It is recommended to stop taking this medicine at least 72 hours before the test.

Children

Do not use this medicine in children under 12 years of age.

Using Chiclida with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or may take any other medicine.

The following are not recommended to be taken in combination with Chiclida:

• Central nervous system depressants, such as anesthetics, opioid analgesics, barbiturates (used as sedatives, anticonvulsants, and for sleep disorders), benzodiazepines (for sleep), antipsychotics.
• Antiparkinsonian medicines.
• Antidepressants.
• Neuroleptics (used to calm excitement and neuromuscular hyperactivity).

Taking Chiclida with food, drinks, and alcohol

Alcoholic beverages may enhance the effect of Meclozine, so it is not recommended to take them simultaneously.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

It should not be used during pregnancy, unless strictly necessary. Do not administer during breastfeeding.

Driving and using machines

Chiclida may cause drowsiness, which may affect your ability to drive and/or operate machines. Patients should avoid operating hazardous machinery, including automobiles, until they know how they tolerate the medicine.

Chiclida contains glucose and sucrose

This medicine contains glucose and sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

It may cause tooth decay.

3. How to take Chiclida

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor. In case of doubt, ask your doctor or pharmacist.

Adults and adolescents (over 12 years of age): 1 or 2 lozenges of Chiclida (25 mg - 50 mg meclozine hydrochloride) approximately 1 hour before starting the trip. If necessary, repeat the dose every 24 hours. Do not exceed the dose of 2 lozenges of Chiclida (50 mg of meclozine hydrochloride) per day.

Patient with renal and/or hepatic insufficiency: It may be necessary to reduce the dose (see section 2 Warnings and precautions).

Suck the lozenge. Do not swallow.

Administer at least 1 hour before starting the trip.

If the symptoms worsen or persist for more than 7 days, you should consult a doctor.

Use in children

Chiclida is contraindicated in children under 6 years of age.

It is not recommended to administer this medicine to children between 6 and 12 years of age.

If you take more Chiclida than you should

You should consult your doctor or pharmacist immediately.

The symptoms of an overdose may vary, from sedation, difficulty breathing, loss of consciousness to insomnia, hallucinations, tremors, or convulsions.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service. Phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Chiclida

Do not take a double dose to make up for forgotten doses.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you think any of the side effects you are experiencing are serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

If you have a severe allergic reaction (anaphylactic shock) with rash, itching, difficulty breathing, stop taking the medicine and seek medical help immediately.

The most common side effects are drowsiness and sedation. Dry mouth, blurred vision, nausea, vomiting, and joint pain occur rarely (may affect up to 1 in 1,000 patients).

Other side effects of unknown frequency (cannot be estimated from the available data) are:

• Abdominal pain, diarrhea, and constipation.
• Sleepiness and sedation.
• Increased bronchial secretion.
• Increased appetite, anorexia.
• Anxiety, euphoria, irritability, hallucinations, insomnia, memory disorders, psychotic disorders, confusion, and paranoia.
• Dizziness, headache, movement disorders (e.g., Parkinson's disease), paresthesia (tingling and numbness sensation).
• Double vision.
• Vertigo, tinnitus (internal ear noises).
• Dry throat and nose, bronchospasm (contraction of the bronchi), epistaxis (nosebleed).
• Dysuria (difficult, painful, and incomplete urination), polyuria (production and excretion of large amounts of urine), urinary retention.
• Fatigue, weakness.
• Tachycardia, palpitations, and/or arrhythmias.
• Hypotension (decreased blood pressure).
• Hyperexcitability may occur, especially in children.
• Decrease in the number of red blood cells, white blood cells, leukocytes, and platelets in the blood.
• Allergic reactions on the skin and sensitivity to sunlight, after intense exposure, which may cause itching and redness of the skin.
• Weight gain.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Chiclida

No special storage conditions are required.

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Chiclida

The active substance is Meclozine hydrochloride. Each lozenge contains 25 mg of meclozine hydrochloride.

The other ingredients are: glucose monohydrate, sucrose, peppermint flavor, and magnesium stearate. See section 2 "Chiclida contains glucose and sucrose".

Appearance of the product and pack contents

Oval-shaped lozenges, white in color.

Each pack contains 6 lozenges.

Marketing authorization holder and manufacturer

Marketing authorization holder

Name: Fleer Española, S.L.

Address: Rambla Catalunya Nº. 53 ático

City: 08007-Barcelona

Manufacturer:

Name: Fleer Española, S.L.

Address: 08795 – Olesa de Bonesvalls (Barcelona) Phone: 93 898 40 11 Fax: 93 898 41 76

Date of the last revision of this leaflet: January 2015

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)

http://aemps.gob.es